Pharmaceutical Tablet Dosage Form Research Articles

Derivative Spectrophotometic Methods for Simultaneous Estimation of Acetaminophen and Guaiphenesin in their Combined Dosage Form

Derivative spectroscopy offers a useful approach for the analysis of drugs in mixtures. In this study First order derivative spectrophotometric method was developed for the simultaneous determination of Acetaminophen (ACET) and Guaiphenesin (GUAI) in bulk and combined tablet dosage form. The derivative spectrum for the method was obtained in methanol and the linearity was obtained in the concentration range of 2.0 - 10.0 µg/mL for Acetaminophen and 1.2 - 6.1 µg/mL for Guaiphenesin. The zero order spectrums are obtained at wavelengths 250nm for Acetaminophen and 274nm for Guaiphenesin. First order derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The determinations were made at 209 nm (ZCP of Guaiphenesin) for Acetaminophen and 250 nm (ZCP of Acetaminophen) for Guaiphenesin. The mean % recovery was 100.4 and 99.8 % for Acetaminophen and Guaiphenesin respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of Acetaminophen and Guaiphenesin in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.

A Validated Reversed-Phase HPLC Method for the Determination of Vildagliptin from Tablet Dosage Form

A simple, rapid, precise and cost effective method has been developed and validated for determination of Vildagliptin in pharmaceutical tablet dosage form. The chromatographic separation was carried out with Shimpack VP-ODS, 150 × 4.6 mm, 5?m analytical column and mobile phase containing 0.02M phosphate buffer (pH 4.6) and acetonitrile at the ratio (80:20% v/v). pH of the buffer solution was adjusted with orthophosphoric acid. The instrumental settings include flow rate 0.7 ml/min, column temperature at 25ºC and detector wavelength of 210nm using a photodiode array detector. Theoretical plate for Vildagliptin was 6219 and tailing factor was 1.38. DOI: http://dx.doi.org/10.3329/ijpls.v2i3.15455 International Journal of Pharmaceutical and Life Sciences Vol.2(3) 2013: 90-98

An Improved Rapid HPLC Method for the Separation of Five Anti-Hypertensive Agents Using C18 Column: Application to Hydrochlorothiazide Determination in Bulk and Tablet Dosage Form

A selective, sensitive and accurate HPLC method with UV detection was developed and validated for the separation of five anti-hypertensive agents and applied for the determination of hydrochlorothiazide in bulk and pharmaceutical dosage forms. One of the key goals of HPLC technique is to achieve a consistent and reproducible separation. RP-HPLC method was developed by using Welchrom C18 Column (4.6 mm i.d. X 250 mm, 5 μm particle size), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase constituted of 10 mM Phosphate buffer (pH3.0, adjusted with triethylamine): acetonitrile (50:50, v/v).The flow rate was set to 1.0 mL/min with the responses measured at 235nm using Shimadzu SPD20A Prominence UV-Visible detector. The retention times of atenolol hydrochloride, metoprolol succinate, hydrochlorothiazide, amlodipine besylate and nebivolol hydrochloride were found to be 2.303 min, 2.827 min, 3.543 min, 4.253 min and 4.957 min respectively. This method successfully separated all five antihypertensive drugs in less than 6 min. Hydrochlorothiazide was found to give linear response in the concentration range of 2-10μg/mL. Recovery studies were performed to ascertain the accuracy by standard addition method and average recovery was found to be 99.70 to 100.17 %.The limit of detection and limit of quantification were found to be 0.126616 μg/mL and 0.383686 μg/mL respectively. The developed method can be used for routine quality control analysis of hydrochlorothiazide in pharmaceutical tablet dosage form. It can also be extended for the determination of other four anti-hypertensive agents. This method provides simple and fast method with excellent peak symmetry and high resolution.

Validation and Application of a New Reversed Phase HPLC Method forIn VitroDissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets

The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, 100 × 4.6 mm ID, and 10 μm particle size column, and injection volume was 20 μL using a diode array detector (DAD) to monitor the detection at 280 nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60 : 40 (v/v), and the flow rate was maintained at 1.0 mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05–12.0 μg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis.

DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION DICLOXACILLIN AND CEFDOXIME PROXETIL IN TABLET DOSAGE FORM

The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of dicloxacillin and cefdoxime proxetil in combined tablet dosage form. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra was obtained in methanol and the determinations were made at 233.8 nm (ZCP of cefdoxime proxetil) for dicloxacillin and 321 nm (ZCP of dicloxacillin) for cefdoxime proxetil. The linearity was obtained in the concentration range of 10-80 μg/ml for dicloxacillin and 4-32 μg/ml for cefdoxime proxetil. The mean recovery was 100.70 ± 0.38 and 99.90 ± 0.36 for dicloxacillin and cefdoxime proxetil, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of dicloxacillin and cefdoxime proxetil in pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.

Development and validation of the simultaneous UV spectrophotometric method for estimation of metoprolol succinate and olmesartan medoxomil in the tablet dosage form

Introduction: A simple, rapid, accurate, precise, and economical UV spectrophotometric method for the simultaneous determination of metoprolol succinate (METO) and olmesartan medoxomil (OLME) in a combined tablet dosage form using the simultaneous equation method has been developed. Materials and Methods: The method is based on the simultaneous equations for analysis of both the drugs using distilled water as a solvent. METO has absorbance maxima at 221nm and OLME has absorbance maxima at 257nm in distilled water. Results: The linearity was obtained in the concentration range of 5–25μg/ml and 4–20μg/ml for METO and OLME, respectively. The concentrations of the drugs were determined by using the simultaneous equations method. The mean recovery was 100.90 ± 1.76 and 100.26 ± 0.71 for METO and OLME, respectively. Conclusion: The method was found to be simple, accurate, and precise and was applicable for the simultaneous determination of METO and OLME in the pharmaceutical tablet dosage form. The results of analysis have been validated statistically and by recovery studies.

Analytical Method Development & Validation Protocol For Trospium Chloride In Tablet Dosage Form

Trospium Chloride is an antispasmodic, antimuscarinic agent. It is used in the treatment of overactive bladder with urge incontinence. It is also used as anticholinergic compound. It acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. It appears as white crystalline powder. It is very soluble in water, freely soluble in methanol and practically insoluble in methylene chloride. A simple spectrophotometric method was developed for the determination of Trospium Chloride in pharmaceutical tablet dosage form. Trospium Chloride exhibiting λ max at 224 nm in mobile phase (0.1 N HCl ) and obeyed linearity in the concentration range of 10 – 60 mcg. The proposed method was statistically validated. © 2011 IGJPS. All rights reserved

Spectrophotometric method development and validation of itopride hydrochloride in bulk and dosage form.

A simple, precise and economical spectrophotometric method for the estimation of Itopride hydrochloride in pharmaceutical bulk and tablet dosage form was developed and validated. Identification was carried out using a UV-visible double beam spectrophotometer detector with working wavelength at 258nm in 0.1N HCl medium. The method was validated with respect to its specificity, linearity range, accuracy, and precision in analytical media. Itopride hydrochloride show the maximum absorbance (λmax) at 258 nm, Regression analysis showed good correlation in the concentration range 5-100 mcg/ml and 96.80 to 106.84% recovery with relative standard deviation 0.293 to 3.98%. Statistical treatment of data reflects that the proposed method is precise, accurate and easily applicable for determination of Itopride hydrochloride in bulk and pharmaceutical preparation. Keywords: Spectrophotometric; Itopride hydrochloride; Validation.

Development and Statistical Validation of Spectrophotometric Methods for the Estimation of Nabumetone in Tablet Dosage Form

Three new simple, economic spectrophotometric methods were developed and validated for the estimation of nabumetone in bulk and tablet dosage form. First method includes determination of nabumetone at absorption maxima 330 nm, second method applied was area under curve for analysis of nabumetone in the wavelength range of 326‐334 nm and third method was First order derivative spectra with scaling factor 4. Beer law obeyed in the concentration range of 10‐30 μg/mL for all three methods. The correlation coefficients were found to be 0.9997, 0.9998 and 0.9998 by absorption maxima, area under curve and first order derivative spectra. Results of analysis were validated statistically and by performing recovery studies. The mean percent recoveries were found satisfactory for all three methods. The developed methods were also compared statistically using one way ANOVA. The proposed methods have been successfully applied for the estimation of nabumetone in bulk and pharmaceutical tablet dosage form.

Spectrophotometric Estimation of Amoxicillin Trihydrate in Bulk and Pharmaceutical Dosage Form

New simple, sensitive, rapid, reproducible and economical spectrophotometric method have been developed for the determination of amoxicillin trihydrate in pharmaceutical bulk and tablet dosage form using citro phosphate buffer pH 7.2. The system obeys Lambert‐Beer′s law at 231 nm in the concentration range 2.5‐50 μg/m. Molar absorptivity, correlation coefficient and Sandell′s sensitivity values were found to be 1.0020 x 104 mol-1 cm, -1 0.9996 and 0.03906 μg cm-2 respectively. The proposed methods have been successfully applied to the analysis of the bulk drug and its tablet dosage form. The methods have been statistically evaluated and were found to be precise and accurate

Spectrophotometric Determination of Raloxifene Hydrochloride in Pharmaceutical Formulations

Three new simple, sensitive, rapid and economical spectrophotometric Methods (A, B and C) have been developed for the determination of Raloxifene Hydrochloride in pharmaceutical bulk and tablet dosage form. Method A is based on the formation of yellow colored chromogen with 0.1N Sodium hydroxide exhibiting maximum absorbance against the corresponding reagent blank. The method B is based on the reaction of Raloxifene with Ferric chloride and 1, 10‐phenanthroline to form blood red colored chromogen. The method C is based on the formation of blood red colored chromogen with Ferric chloride and 2, 2′ bipyridyl. The absorbencies of the chromogens were measured at their respective wavelength of maximum absorbance against the corresponding reagent blank. The proposed methods have been successfully applied to the analysis of the bulk drug and its tablet dosage form. The methods have been statistically evaluated and were found to be precise and accurate.

Some physical properties of tabletted Bridelia ferrugnea leaf extract

This paper is an attempt to formulating an indigenous medicinal plant into a modern pharmaceutical tablet dosage form. The dried lead extract of B. ferruginea was formulated into tablets dosage forms using three standard binders at concentration levels of 2–8%w/w. Some physical properties of the tablets such as hardness, friability, disintegration time, dissolution rate and content uniformity were evaluated. The tablets had satisfactory physical properties with exception of those batches containing 4–8%w/w SCMC that failed the disintegration test. Tablets containing SCMC also showed the highest hardness and least friability. Since most of the tablet batches had satisfactory physical properties, it is possible to employ the named binders in the formulation of the conventional tablets of B. ferruginea . Bio-Research Vol. 3(1) 2005: 85-88

Spectrophometric Determination of Nelfinavir Mesylate

Two new simple, sensitive, rapid and economical Spectrophotometric Methods (A and B) have been developed for the determination of Nelfinavir Mesylate in pharmaceutical bulk and tablet dosage form. The method A is based on the reaction of Nelfinavir with ferric chloride, potassium ferricyanide and hydrochloric acid to form a bluish green colored chromogen. The Method B is based on the formation of blood red colored chromogen with Ferric chloride and 1,10‐phenanthroline. The absorbances of the chromogen were measured at their respective wavelength of maximum absorbance against the corresponding reagent blank. The proposed methods have been successfully applied to the analysis of the bulk drug and its tablet dosage form. The methods have been statistically evaluated and were found to be precise and accurate.

Determination of Conjugated and Esterified Estrogens in Pharmaceutical Tablet Dosage Forms by High-Pressure, Normal-Phase Partition Chromatography

A high-pressure, normal-phase partition chromatographic method for the identification and determination of conjugated and esterified estrogens in pharmaceutical tablet dosage forms is described. The method is based on the separation of the estrogen sulfate esters on a conventional diatomaceous earth-H20 column, followed by HCI-methanol hydrolysis, and finally a chromatographic separation on a chemically bonded ether (ETH-Permaphase) column and measurement. Mobile phases found useful were combinations of 2-propanol and n-heptane. Equillin and -dehydroestrone, a structurally related isomer, not separately determined in the proposed method, are determined as a sum by performing a chromatographic study of their corresponding 2, 4-dinitrophenylhydrazine derivatives. Studies have indicated several estrogen derivatives can be rapidly formed and then separated on the same column, providing a useful qualitative analysis scheme. Commercial tablet dosage forms were analyzed for conjugated and esterified estrogens and the results are presented.